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Completed

NCT Number: NCT05345314

Endoscopic Grading of Intestinal Metaplasia

Long-term Helicobacter pylori infection causes premalignant gastric conditions, such as atrophic gastritis and intestinal metaplasia. Image-enhanced endoscopy techniques such as narrow-band imaging (NBI) and magnifying endoscopy improve the diagnosis of gastric intestinal metaplasia (GIM). However, there are no comparative data on the utility of NBI and magnifying endoscopy for diagnosing GIM.

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Key information

Conditions

Narrow-band Imaging Gastric Intestinal Metaplasia Magnifying Endoscopy

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Digestive Disease Center, Soonchunhyang University Hospital

Seoul, 140-887, South Korea

About this study

This study aims to evaluate the diagnostic performance of NBI and magnifying endoscopy for GIM in a country with high risk of gastric premalignant lesions.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gastroscopy can be performed
  • Pathological analysis can be performed for analysis of gastric atrophy and intestinal metaplasia

Exclusion criteria

  • Age < 20 or > 80 years
  • Anemia (serum hemoglobin level < 10 g/dL)
  • Severe systemic disease
  • Advanced chronic liver disease
  • Use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics
  • History of H. pylori eradication
  • History of gastric surgery
  • Recent history of upper gastrointestinal bleeding

Treatment and study plan

Narrow-band imaging endoscopy

Procedure

During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.

Primary outcomes

  1. Gastric intestinal metaplasia

    Time frame: 4 weeks

    Gastric intestinal metaplasia would be assessed using pathological examination.

Secondary outcomes

  1. Degree of chronic gastritis

    Time frame: 4 weeks

    Gastric atrophy would be evaluated on the basis of histopathological examination (updated Sydney system).

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Registry information

Official study title

Endoscopic Grading of Gastric Intestinal Metaplasia: a Validation Study in Korea

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 25, 2022
Registry last updated
Apr 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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